Decellularized human amniotic membrane: From animal models to clinical trials.

ABSTRACT

The efficacy of decellularized products for healing of acute and chronic wounds mostly relies on physical and chemical properties, processing methods and host response. Human Amniotic Membrane (HAM) is considered as an effective and highly used wound dressing in clinic. According to the proposed decellularization protocols for developing of HAM, we have compared different protocols to introduce the most efficient methods, which can be used as a functional dermal matrix. In this study, different methods of HAM decellularization were used to achieve an optimal process. After achievement of appropriate decellularized method in vitro the amniotic membrane were examined in term of animal in vivo study and human clinical trial. The results of in vitro and in vivo assay indicate that the HAMs which were prepared with peracetic acid (2 M) had a significantly different in term of GAGs quantification, DNA isolation and quantification, histological assessment, collagen analysis, Cell-Tissue Interaction Study and cytotoxicity (P < 0/05). Tissue samples treated with peracetic acid (2 M) were more acceptable than that of samples prepared with other protocols in terms of preserving natural components and structure and removing of cell fragments. The peracetic acid-processed HAM was further functionally evaluated through in vivo assessments that can further lead to tissue reconstruction within the human host.